Clinical Research Associate

About the Company

ARTIDIS AG is a clinical-stage health-tech start-up company founded in Basel, Switzerland that has developed the first nanomechanical biomarker for cancer diagnosis and treatment optimization. The ARTIDIS nanotechnology platform integrates different types of clinical data into the ARTIDISNET digital platform.

Responsibilities

• Participate in the design, planning, and implementation of clinical studies, including tracking site activation, patient recruitment, and data collection
• Review and update study protocols and documents in adherence to regulatory, GCP, and QMS requirements
• Prepare and manage submissions to Ethics Committees (ECs), Institutional Review Boards (IRBs), and Regulatory Authorities (RAs)
• Conduct site selection, initiation, monitoring, and close-out visits
• Act as the primary liaison between study sites, vendors, and the internal study team
• Support data management activities, including data entry, query resolution, and data review
• Oversee safety reporting to ensure compliance with study protocols
• Maintain accurate and complete documentation of the Trial Master File globally
• Provide training and ongoing support to investigators and site staff

Requirements

• Bachelor’s degree in a scientific discipline or equivalent experience
• Hands-on experience conducting clinical studies, including single-center and international multi-center studies with medical devices
• Strong knowledge of regulatory guidelines and GCP standards for medical devices
• Proficiency in Croatian and English (written and spoken)
• Ability to travel approximately 20%

Preferred Qualifications

• Familiarity with clinical/health systems
• Experience with ISO14155:2020, ISO 20916:2019, and/or ICH-GCP E6(R2)